BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris Pump Module model 8100

    Recall: Z-2700-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2700-2017
    Event ID
    77279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    June 12, 2017
    Classification Date
    July 7, 2017
    Termination Date
    January 28, 2019
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris Pump Module model 8100

    Reason

    There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.

    Code Info

    Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

    Distribution

    US and Canada

    Quantity

    35,940 units